MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM50 FETAL MONITOR

Model Number 865071

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  Injury  

Event Description

The customer requested documenting concerning (b)(4) or service history of a fco being applied to the device in question.A philips product support engineer (pse) provided another fco (b)(4) in which the serial number was listed on the can application layer (cal).A philips regional service manager (rsm) followed up with customer, and told them philips will continue to research the request and that the initial fco was for an addendum to the instruction for use ifu.At the time of the follow-up, the customer indicated they wanted to be transparent that the reason why they are asking for the documentation was due to pending litigation.It is unknown if the device was in clinical use.The report was marked as patient harm.The nature of the harm was not provided at the time of this report.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

H3 other text : no alleged product malfunction.

Event Description

The customer requested documenting concerning fco86201075a or service history of a fco being applied to the device in question.A philips product support engineer (pse) provided another fco 86201218a in which the serial number was listed on the can application layer (cal).A philips regional service manager (rsm) followed up with customer, and told them philips will continue to research the request and that the initial fco was for an addendum to the instruction for use ifu.At the time of the follow-up, the customer indicated they wanted to be transparent that the reason why they are asking for the documentation was due to pending litigation.It is unknown if the device was in clinical use.The report was marked as patient harm.The nature of the harm was not provided at the time of this report.After further investigation, this complaint was deemed not a reportable event with philips.The customer requested documentation concerning fco86201075a or service history of a fco being applied to the device in question.A philips product support engineer (pse) provided another fco 86201218a in which the serial number was listed on the can application layer (cal).A philips regional service manager (rsm) followed up with customer, and told them philips will continue to research the request and that the initial fco was for an addendum to the instruction for use ifu.At the time of the follow-up investigation, the customer indicated they wanted to be transparent that the reason why they are asking for the documentation was due to pending litigation.The customer confirmed that there was no patient harm associated with this request.The customer was requesting the service history regarding the involved device.

• Brand Name: AVALON FM50 FETAL MONITOR
• Type of Device: AVALON FM50 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15614836
• MDR Text Key: 301827792
• Report Number: 9610816-2022-00524
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865071
• Device Catalogue Number: 865071
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other